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Completed

NCT Number: NCT00543907

Outcomes of a Deep Inferior Epigastric Perforator Flap Program

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intraductal carcinoma
  • Lobular carcinoma
  • Infiltrating ductal carcinoma
  • Paget's disease
  • BRCA positive

Exclusion criteria

  • Inflammatory carcinoma of the breast

Treatment and study plan

Primary outcomes

  1. complication rate

    Time frame: 6 years

    complication rate

Secondary outcomes

  1. reconstruction rate

    Time frame: 6 years

    reconstruction rate

  2. patient satisfaction

    Time frame: 6 years

    Breast Q, Michigan Breast Outcomes Survey

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2007
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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